A Phase II Study of Docetaxel Alone or with OGX-427 in Patients with Recurrent or Refractory Urothelial Cancers

Protocol

13-127

Full Title

A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Combination with OGX-427 in Patients with Relapsed or Refractory Metastatic Urothelial Carcinoma after Receiving a Platinum-containing Regimen

Phase

II

Disease Status

Relapsed/Refractory

Purpose

The purpose of this study is to see if treatment with the drugs docetaxel and OGX-427 is more effective for prolonging survival than docetaxel alone in patients with urothelial cancers (those of the bladder, urethra, ureter, and renal pelvis) that have returned or persisted despite prior treatment with cisplatin or carboplatin. Docetaxel is an approved anticancer drug that is widely used to treat a variety of cancers, including advanced bladder cancer.

OGX-427 is an investigational drug that works by inhibiting the activity of a protein called Hsp27. This protein is produced in large quantities by cancer cells and protects them from the lethal effects of anticancer treatments. It is hoped that OGX-427 will make the cancer cells more susceptible to docetaxel and make docetaxel work better.

Patients will be randomly assigned to receive docetaxel plus OGX-427 or docetaxel alone. Both drugs are given intravenously (by vein).

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have inoperable or metastatic urothelial cancer that has returned or continued to grow despite treatment that included cisplatin or carboplatin.

Patients may not have previously received docetaxel or OGX-427.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-422-4461.

Clinical Trials

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